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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05436717
Other study ID # PI22/341
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 15, 2023
Est. completion date December 15, 2023

Study information

Verified date February 2023
Source Hospital Miguel Servet
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Because of the COVID-19 pandemic situation, social and health professionals constitute a population in risk of developing psychopathologies due to the high levels of stress they experience. There is consensus regarding the need of offering these professionals psychotherapeutic evidence-based interventions addressed to reducing their stress levels and promote their wellbeing; because of the current situation, it is believed that online interventions might be the best-fitted approach. The research groups that present this project have leaded a research line that has proved the efficacy of online psychotherapeutic programs in the past. In the present project, the efficacy of the MINDxYOU program will be evaluated; this is an online intervention based on mindfulness techniques, compassion, and acceptance, and that has been developed specifically for social and health professionals. In addition, in order to overcome the gap that separates the validation of interventions and their posterior implementation, this project aims to perform an implementation study in which a hybrid design will be adopted to test the impact of the program in terms of efficacy and the feasibility of the implementation. The investigators will adopt the framework proposed by Hermes. et al., inspired in Proctor's recommendations. The study will be conducted in 2 autonomous communities (Aragón and Andalucía).


Recruitment information / eligibility

Status Recruiting
Enrollment 180
Est. completion date December 15, 2023
Est. primary completion date December 15, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - Working as a doctor, nurse, physiotherapist, psychologist, nursing assistant, ambulance technician, or being a trainee student in any health profession, or working in a nursing home. - Aged between 18 and 70. - Ability to understand Spanish. - Digital literacy and access to a smartphone, tablet, or personal computer with Internet connection. - Giving informed consent. Exclusion Criteria: - Presenting an illness that affects the central nervous system. - Having a diagnosis of a severe psychiatric condition (including severe depressive disorders, suicidal tendencies, bipolar disorders, panic disorders, anxiety or stress-related disorders, obsessive-compulsive disorders, and substance-related disorders). - Presenting a medical, infectious, or degenerative illness that is not under control.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
MINDxYOU
The online program MINDxYOU is based on the principles of 'third wave' psychotherapies and it is an online program particularly addressed at healthcare providers which will both monitor and support the individual's mental health. The program is self-administered and will be delivered via the Internet and available via smartphone, tablet, and personal computer.

Locations

Country Name City State
Spain Department of Psychiatry. Miguel Servet University Hospital Zaragoza

Sponsors (1)

Lead Sponsor Collaborator
Hospital Miguel Servet

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Perceived Stress Scale (PSS) Consists of 10 items in which participants are asked to rate how unpredictable, uncontrollable, and overloaded they have found their life over the past month on a 5-point Likert-type scale. Scores range from 0 to 40, and higher scores reflect higher levels of perceived stress. Baseline
Primary Perceived Stress Scale (PSS) Consists of 10 items in which participants are asked to rate how unpredictable, uncontrollable, and overloaded they have found their life over the past month on a 5-point Likert-type scale. Scores range from 0 to 40, and higher scores reflect higher levels of perceived stress. Post-treatment 10 weeks from baseline
Primary Perceived Stress Scale (PSS) Consists of 10 items in which participants are asked to rate how unpredictable, uncontrollable, and overloaded they have found their life over the past month on a 5-point Likert-type scale. Scores range from 0 to 40, and higher scores reflect higher levels of perceived stress. 6 months follow-up from baseline
Secondary Patient Health Questionnaire (PHQ-9) It is a 9-item scale aimed at screening for depression in primary care and other medical settings. It assesses the frequency of depressive symptoms during the last 2 weeks using a scale from 0 (not at all) to 3 (nearly every day). The total score ranges from 0 to 27, with higher scores indicating higher severity of depression. Baseline
Secondary Patient Health Questionnaire (PHQ-9) It is a 9-item scale aimed at screening for depression in primary care and other medical settings. It assesses the frequency of depressive symptoms during the last 2 weeks using a scale from 0 (not at all) to 3 (nearly every day). The total score ranges from 0 to 27, with higher scores indicating higher severity of depression. Post-treatment 10 weeks from baseline
Secondary Patient Health Questionnaire (PHQ-9) It is a 9-item scale aimed at screening for depression in primary care and other medical settings. It assesses the frequency of depressive symptoms during the last 2 weeks using a scale from 0 (not at all) to 3 (nearly every day). The total score ranges from 0 to 27, with higher scores indicating higher severity of depression. 6 months follow-up from baseline
Secondary General Anxiety Disorder-7 (GAD-7) It is a 7-item self-reported measure to assess the intensity of anxiety symptoms. It refers to the period of the past 2 weeks; each item is scored in a 4-point Likert-type scale, resulting in a total score that can range from 0 to 21, with higher values reflecting more severe anxiety symptoms. Baseline
Secondary General Anxiety Disorder-7 (GAD-7) It is a 7-item self-reported measure to assess the intensity of anxiety symptoms. It refers to the period of the past 2 weeks; each item is scored in a 4-point Likert-type scale, resulting in a total score that can range from 0 to 21, with higher values reflecting more severe anxiety symptoms. Post-treatment 10 weeks from baseline
Secondary General Anxiety Disorder-7 (GAD-7) It is a 7-item self-reported measure to assess the intensity of anxiety symptoms. It refers to the period of the past 2 weeks; each item is scored in a 4-point Likert-type scale, resulting in a total score that can range from 0 to 21, with higher values reflecting more severe anxiety symptoms. 6 months follow-up from baseline
Secondary Brief Symptoms Inventory (BSI) It is a 18-item self-reported questionnaire designed to offer a rapid screening of symptoms of psychological disorders. Each item is scored in a 5-point Likert-type scale, reflecting on the past 7 days. Baseline
Secondary Brief Symptoms Inventory (BSI) It is a 18-item self-reported questionnaire designed to offer a rapid screening of symptoms of psychological disorders. Each item is scored in a 5-point Likert-type scale, reflecting on the past 7 days. Post-treatment 10 weeks from baseline
Secondary Brief Symptoms Inventory (BSI) It is a 18-item self-reported questionnaire designed to offer a rapid screening of symptoms of psychological disorders. Each item is scored in a 5-point Likert-type scale, reflecting on the past 7 days. 6 months follow-up from baseline
Secondary Connor-Davidson Resilience Scale (CD-RISC) It is a 10-item self-reported measure addressed at assessing resilience. Each item is scored in a 5-point Likert scale, and the total score, which ranges from 1 to 5, is calculated by averaging the scores of the items; higher scores indicate higher levels of resilience. Baseline
Secondary Connor-Davidson Resilience Scale (CD-RISC) It is a 10-item self-reported measure addressed at assessing resilience. Each item is scored in a 5-point Likert scale, and the total score, which ranges from 1 to 5, is calculated by averaging the scores of the items; higher scores indicate higher levels of resilience. Post-treatment 10 weeks from baseline
Secondary Connor-Davidson Resilience Scale (CD-RISC) It is a 10-item self-reported measure addressed at assessing resilience. Each item is scored in a 5-point Likert scale, and the total score, which ranges from 1 to 5, is calculated by averaging the scores of the items; higher scores indicate higher levels of resilience. 6 months follow-up from baseline
Secondary Five Facets of Mindfulness Questionnaire -15 item version (FFMQ-15) It is an adaptation of the original 39-item FFMQ, a questionnaire addressed at measuring the five facets of mindfulness. Each subscale of the FFMQ-15 includes 3 items, scored in a Likert-type scale (1-5). A score for each subscale, ranging from 5 to 15, can be computed by summing the items, where higher scores indicate higher levels of the mindfulness facet. Baseline
Secondary Five Facets of Mindfulness Questionnaire -15 item version (FFMQ-15) It is an adaptation of the original 39-item FFMQ, a questionnaire addressed at measuring the five facets of mindfulness. Each subscale of the FFMQ-15 includes 3 items, scored in a Likert-type scale (1-5). A score for each subscale, ranging from 5 to 15, can be computed by summing the items, where higher scores indicate higher levels of the mindfulness facet. Post-treatment 10 weeks from baseline
Secondary Five Facets of Mindfulness Questionnaire -15 item version (FFMQ-15) It is an adaptation of the original 39-item FFMQ, a questionnaire addressed at measuring the five facets of mindfulness. Each subscale of the FFMQ-15 includes 3 items, scored in a Likert-type scale (1-5). A score for each subscale, ranging from 5 to 15, can be computed by summing the items, where higher scores indicate higher levels of the mindfulness facet. 6 months follow-up from baseline
Secondary Sussex-Oxford Compassion Scales (SOCS) This scale is composed by two 20-item self-report scales measuring compassion. A total score, ranging from 20 to 100, is calculated for each scale, and higher total values indicate higher levels of compassion Baseline
Secondary Sussex-Oxford Compassion Scales (SOCS) This scale is composed by two 20-item self-report scales measuring compassion. A total score, ranging from 20 to 100, is calculated for each scale, and higher total values indicate higher levels of compassion Post-treatment 10 weeks from baseline
Secondary Sussex-Oxford Compassion Scales (SOCS) This scale is composed by two 20-item self-report scales measuring compassion. A total score, ranging from 20 to 100, is calculated for each scale, and higher total values indicate higher levels of compassion 6 months follow-up from baseline
Secondary Acceptance and Action Questionnaire-II (AAQ-II) It is a measure for assessing experiential avoidance, a key element of 'third wave' psychotherapies that refers to the tendency to avoid thoughts, feelings, memories, sensations and other internal experiences, and which is very commonly associated with worse mental health outcomes, as opposite to psychological flexibility. The scale presents 7 items scored in a 7-point Likert-type scale, and a total score is calculated by summing all the items. Higher scores mean higher experiential avoidance. Baseline
Secondary Acceptance and Action Questionnaire-II (AAQ-II) It is a measure for assessing experiential avoidance, a key element of 'third wave' psychotherapies that refers to the tendency to avoid thoughts, feelings, memories, sensations and other internal experiences, and which is very commonly associated with worse mental health outcomes, as opposite to psychological flexibility. The scale presents 7 items scored in a 7-point Likert-type scale, and a total score is calculated by summing all the items. Higher scores mean higher experiential avoidance. Post-treatment 10 weeks from baseline
Secondary Acceptance and Action Questionnaire-II (AAQ-II) It is a measure for assessing experiential avoidance, a key element of 'third wave' psychotherapies that refers to the tendency to avoid thoughts, feelings, memories, sensations and other internal experiences, and which is very commonly associated with worse mental health outcomes, as opposite to psychological flexibility. The scale presents 7 items scored in a 7-point Likert-type scale, and a total score is calculated by summing all the items. Higher scores mean higher experiential avoidance. 6 months follow-up from baseline
Secondary EuroQol five-dimensional classification system (EQ-5D) It is a widely used health-related quality of life measure. First, the participant is asked to report how severe (1= no problems, 2= mild, 3= moderate, 4= severe, 5= extreme) are the problems they may present in the day of reporting regarding each of the following five domains: mobility, self-care, usual activities, pain, and anxiety/depression. The utility scores are obtained from the EQ-5D classification system and are used to rate patients' health-related quality of life, which normally range from 0 (although it is possible to present negative scores) to 1 (i.e., "perfect health"). Baseline
Secondary EuroQol five-dimensional classification system (EQ-5D) It is a widely used health-related quality of life measure. First, the participant is asked to report how severe (1= no problems, 2= mild, 3= moderate, 4= severe, 5= extreme) are the problems they may present in the day of reporting regarding each of the following five domains: mobility, self-care, usual activities, pain, and anxiety/depression. The utility scores are obtained from the EQ-5D classification system and are used to rate patients' health-related quality of life, which normally range from 0 (although it is possible to present negative scores) to 1 (i.e., "perfect health"). 6 months follow-up from baseline
Secondary Client Service Receipt Inventory (CSRI) It is addressed at describe and measure service utilization patterns as a basis for estimating associated costs across healthcare, social care and community settings. Baseline
Secondary Client Service Receipt Inventory (CSRI) It is addressed at describe and measure service utilization patterns as a basis for estimating associated costs across healthcare, social care and community settings. 6 months follow-up from baseline
Secondary System Usability Scale (SUS) It is a 10-item questionnaire to measure the usability which qualitatively is related with the quality and acceptability of the intervention. The scale presents 5-point Likert-type scale (0 = never, 1 = almost never, 2 = often, 3 = sometimes and 4 = always). A total score, ranging from 0 to 40, is calculated by totalling the scores from all the items, and higher total values indicate higher level of acceptability of the intervention Post-treatment 10 weeks from baseline
Secondary Client Satisfaction Questionnaire adapted to Internet-Based interventions (CSQ-I) It is an 8-item, 4-point Likert scale questionnaire that assesses the general satisfaction of the participants regarding the received intervention. The total score ranges from 8 to 32. Post-treatment 10 weeks from baseline
Secondary Intervention Appropriateness Measure (IAM) Includes 4 items designed to measure appropriateness of the intervention. The scale presents 5-point Likert-type scale (1 = completely disagree, 2 = in disagreement, 3 = neither agree nor disagree, 4 = agree and 5 = completely agree). A total score, ranging from 0 to 20, is calculated by totalling the scores from all the items, and higher total values indicate higher level of appropriateness of the intervention Post-treatment 10 weeks from baseline
Secondary Attitudes towards Psychological Online Interventions (APOI) Includes 16 items to assess attitudes toward online interventions among people with depressive symptomatology. The APOI explores four dimensions; "Skepticism and Perception of Risks", "Confidence in Effectiveness", "Technologization Threat" and "Anonymity Benefits". Each factor is calculated from the sum of 4 specific items. The scale presents 5-point Likert-type scale (1 = totally agree, 2 = agree, 3 = I'm not sure, 4 = disagree and 5 = totally disagree). Each factor can get a score between 4-20 points, and the higher the score, the greater the sensation perceived by the participant in each of the factors. Post-treatment 10 weeks from baseline
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